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With the introduction of the updated FDA guidance on process validation, a process validation life cycle was introduced in 2011. One of the stages in the cycle is the so-called Continued Process Verification stage 3, which shows whether the process remains permanently in a validated state. Many companies use statistical process control (SPC) to show the 'state of control' in this stage 3.

隨著2011年新版 FDA 工藝驗證指南的推出，引入了工藝驗證生命周期概念。該周期的其中一個階段即所謂的持續(xù)工藝確認(rèn)-階段 3，它提示工藝是否持續(xù)保持驗證狀態(tài)。許多公司使用統(tǒng)計過程控制 （SPC） 來顯示此階段的“受控狀態(tài)” 。

In a recent Warning Letter, the FDA criticised a drug manufacturer's statistical process control. What was criticised?

在FDA最近給EyePoint Pharmaceuticals, Inc.的警告信中，F(xiàn)DA 批評了該藥品制造商的統(tǒng)計過程控制。批評了什么？

No control charts created

未創(chuàng)建控制圖

The methods used in the 'Continued Process Verification' to show the 'state of control' are not specified. One possibility mentioned in the Process Validation Guidance is statistical process control. This is what the company inspected by the FDA had planned.

法規(guī)沒有規(guī)定在 “持續(xù)工藝確認(rèn)”中用于展示“受控狀態(tài)”的方法。FDA的工藝驗證指南中提到的一種可能性是使用統(tǒng)計過程控制。即FDA所檢查的這家公司所計劃要做的。

Was it intended that way? Yes, that is how it was intended. Citing section 21 CFR 210/211, the FDA criticises the lack of activities that show that the process is permanently 'under control'. They are referring to the manufacturing and engineering departments, which have not created control charts to monitor and control the manufacturing process. This is exactly what the company had specified in its internal procedures. This was rectified during the inspection, with the result that four previously undetected trends were discovered. The usefulness of an SPC was thus demonstrated directly during the inspection.

這是有意設(shè)計的嗎？當(dāng)然，這就是他的本意。FDA 引用 CFR 210/211 第 21 條，批評該公司缺乏表明工藝持續(xù)“受控”的活動。即生產(chǎn)和工程部門，尚未創(chuàng)建控制圖來監(jiān)視和控制生產(chǎn)過程。這正是公司在其內(nèi)部程序中所規(guī)定的。在檢查過程中該公司對此采取了糾正措施（即重新制作了控制圖），結(jié)果發(fā)現(xiàn)了四個以前未被發(fā)現(xiàn)的不良趨勢。因此，SPC 的有用性在檢查過程中直接得到了證明。

The inspected company also recognised this and responded to the inspection report by stating that it was committed to complying with its internal procedures on SPC in future. This was not enough for the FDA. It also expects an investigation into how it was possible that the control charts were not created in the first place.

受檢查公司也認(rèn)識到了這一點，并在檢查報告中回應(yīng)說，它承諾將來會遵守其關(guān)于 SPC 的內(nèi)部程序。這對FDA 來說還不夠。FDA還希望調(diào)查為何最初沒有創(chuàng)建控制圖？

Scientific approaches in the context of process validation

工藝驗證的科學(xué)方法

One of the innovations in the update of the FDA Process Validation Guidance was the introduction of a more scientific approach to process validation. This is also clearly reflected in this Warning Letter. The FDA criticises an unscientific approach to a validation run. The mixing uniformity was criticised as insufficient in terms of sample locations and sampling (number, sample size, sample preparation).

FDA 工藝驗證指南更新的創(chuàng)新之一是引入了一種更科學(xué)的工藝驗證方法。這也清楚地反映在這封警告信中。FDA 批評了不科學(xué)的驗證方法。FDA批評其混合均勻性在采樣位置和采樣（采樣點數(shù)量、樣品量、樣品制備）方面存在缺陷。

Conclusion: Statistical process control is not a mandatory requirement in the context of process validation. However, if it is required by internal company specifications, then it must also be implemented. And in this case, the advantage of an SPC was demonstrated very impressively.

結(jié)論：統(tǒng)計過程控制在工藝驗證方面不是強制性要求。但是，如果公司內(nèi)部規(guī)程要求，則也必須實施。在這種情況下，SPC 的優(yōu)勢得到了非常突出的證明。